Sanofi's Lantus, Gilead's Harvoni welcomed to Japan

Sanofi’s next-generation insulin Lantus XR has bagged its first approval in Asia with a green light from Japanese regulators for controlling blood sugar levels in patients with diabetes, offering a new treatment option with a favourable safety profile.

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the drug’s use in both type I and type II forms of the condition, which collectively affect around 9.5 million people in the country.

According to Masato Odawara of Tokyo Medical University, data from clinical trials carried out with Japanese patients show that Lantus XR (insulin glargine) was linked with “less nocturnal hypoglycaemia and no increase in hypoglycaemia at any time of the day,” while blood sugar control was comparable to its predecessor.

A huge proportion of diabetes patients (around 50% globally) on insulin still fail to achieve adequate blood sugar control, and Sanofi will be hoping the potential advantages offered by its next-generation insulin could help address some of this unmet need.

Lantus XR has already been approved by US and EU regulators under the trade name Toujeo.

Harvoni combines Gilead’s mega-blockbuster Sovaldi (sofosbuvir), a nucleotide analogue polymerase inhibitor, with the firm’s the NS5A inhibitor ledipasvir, offering a daily, all-oral interferon- and ribavirin-free treatment option for HCV that is linked with cure rates of up to 100%.

More than one million people in the country suffer from chronic HCV, 70%-80% of which are infected with the genotype 1 strain of the virus. Harvoni has been cleared for the suppression of viraemia in patients with or without compensated cirrhosis, with a treatment duration of 12 weeks.